摘要
目的 建立同时测定多西他赛注射用浓溶液中的溶血磷脂酰乙醇胺（LPE）、溶血磷脂酰胆碱（LPC）含量的HPLC-ELSD。方法 采用YMC Pack PVA-Sil（150mm×2mm,5μm）色谱柱,以三氯甲烷为流动相A、甲醇-水（93.5∶6.5）为流动相B,梯度洗脱,流速为0.4mL·min1,柱温为25℃,蒸发光散射检测器检测,检测器漂移管温度：100℃,雾化气：空气,气体流量为2.0L·min1。结果 LPE和LPC峰面积的对数与相应的浓度的对数呈良好的线性关系,线性范围分别为0.203~0.811μg（r=0.9990）和0.407~6.102μg（r=0.9996）,LPE3个浓度的平均加样回收率分别为104.1%,95.1%,101.6%,RSD分别为3.8%,0.3%,2.4%,LPC3个浓度的平均回收率分别为108.7%,104.5%,105.5%,RSD分别为1.0%,3.0%,2.6%。结论 该法简单、准确、重复性好,可用于多西他赛注射用浓溶液中大豆磷脂分解产物的质量控制。
OBJECTIVE To develop an HPLC-ELSD method for the determination of lyso-phosphatidylcholine（LPC） and lyso-phosphatidylethanolamine（LPE） in Docetaxel Concentrated Solution for Injection. METHODS it was separated with YMC Pack PVA-Sil（150 mm×2 mm, 5 μm） by gradient elution with chloroform as mobile phase A and methanol-water （93.5 ： 6.5） as mobile phase B at a flow rate of 0.4 mL·min^-1. The column temperature was kept at 25 ℃ for separation. The detector was ELSD, of which the drift tube temperature was maintained at 100 ℃ and the flow rate of carrier gas air was kept at 2.0 L.min-1. RESULTS The linear response was calculated by logarithm. The calibration curves were linear in the range of 0.203-0.811 gg（r=0.999 0） for LPE and 0.407-6.102 gg（r=0.999 6） for LPC. The average recovery for LPE was 104.1%, 95.1%, 101.6%, RSD=4.6%; and the average recovery for LPC was 108.7%, 104.5%, 105.5%, RSD=2.7%. CONCLUSION The established method is simple, accurate and reproducible, which can be used for the quality control of Docetaxel Concentrated Solution for Injection,
出处
《中国现代应用药学》
CAS
CSCD
2013年第11期1210-1214,共5页
Chinese Journal of Modern Applied Pharmacy
基金
南京市科技发展计划(201103025)
